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Biowaivers: Practical and Regulatory Approaches

4-week online academy | 2 hours per week

2020 Dates TBC

A biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for approval). As a result, they represent a useful and cost-effective alternative to performing in vivo studies for generic drugs, however they can be challenging to get right first time.  
This course will improve your understanding of various biowaiver types to ensure success in your future applications. Study 8 modules over 4 weeks, using case studies and practical guidance. By examining the requirements for BCS-based, Strength and IVIVC biowaivers, you will have the confidence and skills to implement a strategic approach for new product registrations. 

If you would like to start the course sooner than advertised simply get in contact with our training consultants by emailing [email protected] and we will arrange this for you as soon as possible.

  • Introduction to biopharmacy
  • Understand the legal basis for biowaivers
  • Investigate BCS biowaivers
  • Explore strength biowaivers
  • Understand dissolution data to be submitted
  • Consider applications of IVIVC biowaivers
  • Learn about and compare US-FDA and EMA regulations

Jean-Michel Cardot is a professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. His laboratory research fields are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and IVIVC.

This course is designed for professionals involved in the development/ registration of generic products. Attendees may work in the following areas:

  • Regulatory Affairs
  • Pharmaceutical Development
  • Analytical Development
  • R&D for generics

PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Download the digital training guide.

Watch the Online Academy Video

On average, delegates of our online academies said:

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IVIVC - A Way to Speed up Development Using Dissolution as a Surrogate Tool.

Led by Jean-Michel Cardot, course leader for Practical Solutions for Establishing IVIVC and Bioavailability and Bioequivalence.
In 30 minutes, this webinar explores how to optimise IVIVC using your dissolution data.

Topics covered:

  • Basis of IVIVC
  • Why IVIVC and dissolution are important
  • Use in development: interest and limitations
  • Optimisation of formulation based on IVIVC
  • Conclusions and Q&A session

Testimonials about the course leader:

The trainer was very experienced with many examples and encouraged time for questions.

Regulatory Affairs International Project Manager, Medac GmbH

The trainer was very knowledgeable and had good presentation skills.

Director, Northumbria Pharma

The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.

Regulatory Affairs Development Manager, Regivet BV

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